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Philips Medical Systems (Cleveland) Inc recalls Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross
Recalled December 12, 2018 · FDA recall Z-0545-2019 · Philips Medical Systems (Cleveland)
Hazard
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall · FDA Class II
Units
6,343 units in total
Sold at
US Nationwide Distribution
Description
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Product
Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →